MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

An event of a tear in the left atrium and pericardial effusion was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that the user was unable to remove blood from the sheath, following which the delivery system was removed and reinserted.Please note, per the instructions for use artmt100092315 rev.B, "use caution when advancing the sheath and dilator to avoid damaging tissue.".

Event Description

Related manufacturer report number: 3005334138-2019-00197.On (b)(6) 2019, a pfo procedure was performed.A multipurpose diagnostic catheter was selected but was unable to cross the patient's pfo and was exchanged for an 8f swartz¿ braided transseptal guiding introducer.The defect was sized per the ifu using a 24mm amplatzer sizing balloon ii (lot: 6562638) and a 25mm amplatzer pfo occluder (lot: 6519661) was selected for implant.The 8f amplatzer torqvue delivery system (lot: 6741349) was inserted over the guide wire and the occluder was placed in the defect.The user was unable to remove blood from the sheath, so the user withdrew the delivery system slightly which resulted in the delivery system falling through the pfo into the right atrium.The entire system was removed from the patient, and the 8f swartz¿ braided transseptal guiding introducer (lot: 6823168) was re-inserted across the pfo.The introducer was removed and then the same 8f amplatzer torqvue delivery system was placed and the original 25mm amplatzer pfo occluder was successfully deployed.Prior to release of the occluder, toe was performed, revealing a tear in the left atrium with pericardial effusion.The occluder was implanted and the patient was transferred to surgery.During surgery, the occluder was removed and tear was observed at the roof at the left atrium.The tear was repaired with surgical patch and post-operatively, the patient is reported to be stable.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8503848
• MDR Text Key: 141597317
• Report Number: 2135147-2019-00106
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6519661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention